Granular jelly beverage for medication and process for producing the same

ABSTRACT

Provided is a granular jelly beverage for medication used for taking the crude drug(s) and/or herbal medicine(s), which granular jelly beverage for medication comprises (a) 0.1 to 15.0% by mass of a bitterness masking ingredient comprising a plant fat and oil and/or animal fat and oil; (b) 5.0 to 20.0% by mass of a bitterness masking auxiliary ingredient comprising a sugar alcohol; (c) 0.1 to 5.0% by mass of an aggregation-inhibiting gelling ingredient; (d) 0.1 to 5.0% by mass of at least one taste adjusting ingredient selected from the group consisting of acids, derivatives thereof and salts thereof; and (e) a balance of water.

CROSS REFERENCE TO RELATED APPLICATION

This application is a National Stage of International Application No.PCT/JP2007/069934 filed Oct. 12, 2007, the contents of which isincorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to a granular jelly beverage formedication, which beverage enables tastes of drugs such as crude drugsor herbal medicines having a unique bitter taste, astringent taste, sourtaste or sweet taste to be adjusted and allows the drugs to be safelytaken, as well as a process for producing the granular jelly beveragefor medication.

BACKGROUND ART

Conventionally, drugs for oral application are, in general, taken withwater or plain boiled water. Yet, it is difficult for patients havingdifficulties in swallowing, in particular, the elderly, children and thelike to take drugs with water or plain boiled water.

For the elderly, children and the like, the drug in a form of capsule,tablet or the like is ground and mixed into rice, miso soup or juice tobe taken, which is laborious and complicated. In addition, such a way oftaking the drug makes release time of drug ingredients uncontrollable,inevitably leading to impairment of pharmacological effects and chemicalreactions. Also, it becomes unfeasible to mask the tastes. In somecases, the intended pharmacological effects may not be attained.

The present applicants proposed a low calorie, non-sugarswallowing-assisting beverage, which beverage has a prescribed jellystrength and contains thickening agents such as agar and carrageenan,mannitol and to make the taking of the drug easier while retaining theintended pharmacological effects. A patent has been granted on thisbeverage (See Patent Literature 1).

Further, the present applicants improved the above-mentionedswallowing-assisting beverage and proposed a bitterness masking granularjelly beverage enabling bitterness to be masked even in drugs containinga basic substance with a nitrogen atom such as an amino group (SeePatent Literature 2).

Patent Literature 1: Japanese Patent No. 3257983

Patent Literature 2: WO 2005/025622

Meanwhile, drugs such as crude drugs and herbal medicines are, ingeneral, available mostly in the form of granules. Since each granulehas, in many cases, low specific gravity, when the herbal medicine isput in the mouth together with water, the granule herbal medicine withpowdery or gritty feel floats on the surface of the water, which makesthe swallowing with water difficult. In addition, for crude drugs andherbal medicines, a large dose per one application also causesdifficulties in the swallowing with the water in the mouth.

In order to facilitate the swallowing of these crude drugs and herbalmedicines, it is thought, for example, to use the above-mentionedbitterness masking granular jelly beverage.

Yet, crude drugs and herbal medicines have a unique astringent taste,sour taste or sweet taste in addition to bitterness. Because of this,there are some cases where those drugs do not have a harmonized tastewith the above-mentioned bitterness masking granular jelly beveragewhich contains animal fats and oils and/or plant fats and oils.Consequently, some may rather find more difficult to take the drug.

To improve the taste of the granular jelly beverage after the mixingwith the drug, it can be thought, for example, to add an acidulant orthe like to the granular jelly beverage. However, the simple addition ofthe acidulant causes aggregation of ingredients constituting thegranular jelly beverage and disables appropriate gel formation. Thus,there is a case where the jelly is not formed suitably for coating thedrug.

DISCLOSURE OF THE INVENTION

The present invention was made in light of the above-described problemsin the prior art. An object of the present invention is to provide agranular jelly beverage for medication, which beverage is able to maskbitterness of a drug without its pharmacological effects being lost andto coat the drug such that the drug is readily swallowed, and has a goodtaste even after mixed with the drug, even when the drug is a crude drugand/or herbal medicine which has the bitterness as well as a uniqueastringent taste, sour taste or sweet taste.

As a result of intensive studies for attaining the above-describedobject, the present inventor found that use of a beverage containing abitterness masking ingredient and at least one taste adjustingingredient selected from the group consisting of acids, derivativesthereof and salts thereof, together with one containing anaggregation-inhibiting gelling ingredient, is able to solve theabove-mentioned problems, thereby completing the present invention.

Accordingly, the granular jelly beverage for medication according to thepresent invention is a granular jelly beverage for medication used fortaking a crude drug(s) and/or herbal medicine(s), which granular jellybeverage for medication comprises:

(a) 0.1 to 15.0% by mass of a bitterness masking ingredient comprising aplant fat and oil and/or animal fat and oil;

(b) 5.0 to 20.0% by mass of a bitterness masking auxiliary ingredientcomprising a sugar alcohol;

(c) 0.1 to 5.0% by mass of at least one type of anaggregation-inhibiting gelling ingredient selected from the groupconsisting of carrageenan, gellan gum, locust bean gum, xanthane gum,guar gum, pectin, tapioca starch, and starch;

(d) 0.1 to 5.0% by mass of at least one type of a taste adjustingingredient selected from the group consisting of acids, derivativesthereof and salts thereof; and

(e) a balance of water.

Also, the method for producing the granular jelly beverage formedication according to the present invention is a method comprisingmixing the bitterness masking ingredient (a), the bitterness maskingauxiliary ingredient (b), the aggregation-inhibiting gelling ingredient(c) and at least a part of the water (e) to obtain a mixture; andthereafter mixing the taste adjusting ingredient (d) into the mixture toproduce the granular jelly beverage for medication.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a flow diagram showing an example of the steps of producingthe granular jelly beverage for medication according to the presentinvention.

FIG. 2 is a flow diagram showing another example of the steps ofproducing the granular jelly beverage for medication according to thepresent invention

BEST MODE FOR CARRYING OUT THE INVENTION

The molded article of the present invention will be described in detailbelow. Unless otherwise specified, “%” used herein means percentage bymass.

As described above, the granular jelly beverage for medication accordingto the present invention facilitates the taking of crude drug(s) and/orherbal medicine(s), and comprises (a) 0.1 to 15.0% by mass of thebitterness masking ingredient comprising a plant fat and oil and/oranimal fat and oil; (b) 5.0 to 20.0% by mass of the bitterness maskingauxiliary ingredient comprising a sugar alcohol; (c) 0.1 to 5.0% by massof the aggregation-inhibiting gelling ingredient; (d) 0.1 to 5.0% bymass of at least one taste adjusting ingredient selected from the groupconsisting of acids, derivatives thereof and salts thereof; (e) abalance of water; and, as necessary, (f) 0.01 to 1.5% by mass of theingredient for inhibiting water repellency.

[(a) Bitterness Masking Ingredients]

The bitterness masking ingredient of the granular jelly beverage formedication according to the present invention is at least either plantfats and oils or animal fats and oils. These bind to receptors presenton human taste bud, which receptors sense bitterness, and function toblock binding of bitter ingredients of the drug and the like to thesereceptors.

That is, in human, tastes of food and the like are perceived by tastereceptor organs called the taste buds present near the surface of thetongue. This taste bud measures about 50 μm in diameter. There are tastecells inside the tongue and the receptors sensing bitter tastes, sourtastes, salty tastes or umami tastes are located on the surface of theplasma membrane. And, when bitter substances of the drug which is mixedwith saliva to be an aqueous solution bind to the bitter tastereceptors, an electric potential difference between the inside andoutside of the plasma membrane of the taste cells is altered. Then, thiselectric potential difference is transmitted to the cerebral cortex vianerve fibers. Bitterness is thereby perceived.

In the present invention, the bitterness masking ingredient binds to thebitter taste receptors prior to binding of the bitter ingredients to thereceptors, covers the bitter taste receptors and blocks the bindingbetween the bitter ingredients and bitter taste receptors, therebyinhibiting the excitement of the taste cells and preventing theoccurrence of the electric potential difference.

The above-mentioned animal fats and oils or plant fats and oils are notrestricted as long as those fats and oils fulfill the above-mentionedfunctions. Examples of the plant fats and oils include cacao fats andoils, lecithin, soybean oil, salad oil, edible safflower oil, sunfloweroil, canola oil, corn oil, rice bran oil, peanut oil, olive oil, sesameoil, linseed oil, coconut oil, palm oil, mixed oil, margarine orshortening, and any mixture of these. And, examples of the animal fatsand oils include lard, unsalted butter, butter, cheese, cream, meatfats, fish oils and any mixture of these.

Among these animal fats and oils or plant fats and oils, unsaltedbutter, butter, soybean oil, lecithin, olive oil, corn oil and cacao oilare preferred with cacao fats and oils being most preferred.

Milk, soy milk or extracted components of these, besides theabove-mentioned animal fats and oils or plant fats and oils, may beused.

The content of the bitterness masking ingredient in the granular jellybeverage for medication according to the present invention is 0.10 to15.0%, more preferably 0.20 to 13.0%, still more preferably 0.25 to11.0%.

In cases where the content is less than 0.1%, sufficient bitternessmasking effects cannot be attained whereas the physical property of thejelly is altered and thus a proper jelly strength cannot be obtained incases where the content is more than 15.0%.

[(b) Bitterness Masking Auxiliary Ingredients]

The bitterness masking auxiliary ingredient (b) of the granular jellybeverage for medication according to the present invention is a sugaralcohol. Since this acts as a sweetener, it has auxiliary effects inbitterness masking. Further, the sugar alcohol has a function ofimproving the stability of the gel.

The sugar alcohols are not restricted and examples thereof includehydrogenated maltose starch syrup, hydrogenated starch syrup,hydrogenated lactose, xylitol, erythritol, sorbitol, mannitol and anymixture of these. Among these sugar alcohols, erythritol, hydrogenatedmaltose starch syrup, hydrogenated starch syrup, xylitol and sorbitolare preferred.

The content of the bitterness masking auxiliary ingredient in thegranular jelly beverage for medication according to the presentinvention is 5.0 to 20.0%, preferably 6.0 to 18.0%, more preferably 8.0to 16.0%.

In cases where the content is less than 5.0%, sufficient bitternessmasking auxiliary effects cannot be attained. An addition exceeding20.0% makes the effects saturated and results in no significantdifference.

[(c) Aggregation-Inhibiting Gelling Ingredients]

In the present description, the term “aggregation-inhibiting gellingingredient” refers to those not only inhibiting aggregation of thegranular jelly beverage for medication but also functioning as a gellingagent when the granular jelly beverage for medication is acidic.

The pH of a conventional bitterness masking granular jelly beverage isin a neutral pH range between 5 and 8 such that the beverage coats adrug containing a basic substance which intramolecularly contains anitrogen atom derived from an amino group or the like, facilitates thetaking of the drug, and suppresses perception of bitter taste caused bydrug dissolution in the mouth (See Japanese Patent Application No.2003-321623).

Meanwhile, since an aqueous solution dissolving crude drugs and/or theherbal medicines containing crude drugs is generally acidic, such drugsdo not have a harmonized taste with the bitterness masking granularjelly beverage having a neutral pH range of 5 to 8. Thus, thepalatability deteriorates and some may rather find difficulties inswallowing the drugs. In addition, there are some cases wherepharmacological effects of the herbal medicine are inhibited.

For instance, a simple addition of an acidulant to the above-mentionedgranular jelly beverage such that the beverage has a harmonized tastewith the herbal medicines and the like may result in an aggregation by adeceased solubility of bitterness masking ingredient, gelling ingredientand the like into the beverage, or a chemical reaction, as well as noformation of gels. Therefore, a preferred mode of the granular jelly forcoating the drug may not be attained.

In view of this, by including the aggregation-inhibiting gellingingredient (c) in conjunction with the bitterness masking ingredient(a), the bitterness masking auxiliary ingredient (b) and the tasteadjusting ingredient (d), the present invention improves the taste ofthe granular jelly beverage for medication without the occurrence of anaggregation between the bitterness masking ingredient and the tasteadjusting ingredient, and enables the granular jelly beverage to have ajelly physical property of appropriate solidity and to coat the herbalmedicine or the like, which facilitates the swallowing of even herbalmedicines requiring a large dose or the like.

As the aggregation-inhibiting gelling ingredient which also functions asthe gelling ingredient, at least one selected from the group consistingof carrageenan, gellan gum, locust bean gum, xanthane gum, guar gum,pectin, tapioca starch and starch can preferably be used.

The content of the aggregation-inhibiting gelling ingredient in thegranular jelly beverage for medication according to the presentinvention is 0.1 to 5.0%, preferably 0.1 to 4.0%, more preferably 0.1 to3.0%.

In cases where the content is less than 0.1%, a jelly strength of notless than 10 g/cm² cannot be attained whereas, in cases where it is morethan 5.0%, suitable granules are not formed, leading to the physicalproperty unsuitable for taking a crude drug, herbal medicine or thelike.

[(c-1) Gelling Ingredients]

The granular jelly beverage for medication according to the presentinvention may further contain the gelling ingredient (c-1) in additionto the above-mentioned aggregation-inhibiting gelling ingredient.

As the gelling ingredient (c-1) of the granular jelly beverage formedication according to the present invention, agar, furcellaran,gelatin, curdlan, psyllium seed gum, alginic acid, alginate, mannan,tamarind gum, dextran, carboxymethyl cellulose, carboxymethyl cellulosesodium or any mixture of these can be used in combination.

The content of the aggregation-inhibiting gelling ingredient in thetotal amount of the aggregation-inhibiting gelling ingredient (c) andthe gelling ingredient (c-1) is preferably 2.0 to 100.0%, morepreferably 5.0 to 95.0%, still more preferably 10.0 to 90.0%.

When the content of the aggregation-inhibiting gelling ingredient in thetotal amount of the aggregation-inhibiting gelling ingredient (c) andthe gelling ingredient (c-1) is less than 2.0%, a little aggregation mayoccur after addition of the taste adjusting ingredient, which is notpreferred.

[(d) Taste Adjusting Ingredients]

The granular jelly beverage for medication according to the presentinvention further contains at least one taste adjusting ingredientselected from the group consisting of acids, derivatives thereof andsalts thereof. In cases where the pH of the granular jelly beverage formedication is in an acidic range, the taste does not deteriorate and thepalatability can be improved when mixed with crude drugs, herbalmedicines or the like which have a light sour taste. Because of this,the use of the granular jelly beverage for medication according to thepresent invention enables the drug such as the herbal medicine to bereadily swallowed even in the case of a large dose.

The taste adjusting ingredient is preferably at least one selected fromthe group consisting of adipic acid, L-ascorbic acid, L-asparatic acid,L-arginine, L-glutamic acid, citric acid, glucono delta lactone,gluconic acid, succinic acid, DL-tartaric acid, L-tartaric acid, lacticacid, fumaric acid, butyric acid, DL-malic acid, derivatives thereof andsalts thereof.

Concrete examples thereof include adipic acid, L-ascorbic acid,L-ascorbic acid salts, L-ascorbic acid esters, derivatives of L-ascorbicacid, L-asparatic acid, L-arginine, L-glutamic acid salts, citric acid,citric acid salts, glucono delta lactone, gluconic acid, gluconic acidsalts, succinic acid, succinic acid salts, DL-tartaric acid, L-tartaricacid, lactic acid, lactic acid salts, fumaric acid, fumaric acid salts,butyric acid, derivatives of butyric acid, DL-malic acid and DL-malicacid salts.

Among these acids, derivatives thereof and salts thereof, citric acid,L-ascorbic acid and DL-malic acid are preferred.

The content of the taste adjusting ingredient in the granular jellybeverage for medication according to the present invention is 0.1 to5.0%, preferably 0.1 to 4.0%, more preferably 0.15 to 4.0%.

In cases where the content is less than 0.1%, the taste of the granularjelly beverage for medication cannot be modified so as to have aharmonized taste with crude drugs, herbal medicines or the like. Incases where the content is more than 5.0%, no effects to improve thetaste are expected when the granular jelly beverage for medication ismixed with herbal medicines or the like, and, in addition, anaggregation is likely to occur, which is not preferred.

[(e) Water]

The granular jelly beverage for medication according to the presentinvention contains water. Any water suitable for drinking is sufficientand, for example, tap water, various types of ion-exchanged water,purified water or the like can be used.

The content of the water is not restricted. As long as it is an amountremaining from the amount of other ingredients other than water, inother words, as long as the total amount of each ingredient and water is100%, any amount may be employed.

[(f) Ingredients for Inhibiting Water Repellency]

The granular jelly beverage for medication according to the presentinvention can further contain the ingredient for inhibiting waterrepellency (f) as necessary.

The ingredient for inhibiting water repellency exerts a function toimprove the blending with water by inhibiting the water repellency ofthe above-mentioned bitterness masking ingredient. Additionally, incases where the bitter ingredients described later have poor watersolubility such as lipid solubility, or in cases where a wax coating orpolymer coating is performed during the formulation, the ingredient forinhibiting water repellency has an action of enhancing the affinitybetween those bitter ingredients or the coating and jelly, as well asmaking the coating function more effective.

Concrete examples of such an ingredient for inhibiting water repellencyinclude sucrose fatty acid esters, glycerin fatty acid esters, sorbitanfatty acid esters, propylene glycols, propylene glycol fatty acid estersand any mixture of these.

The content of the ingredient for inhibiting water repellency ispreferably 0.01 to 1.5%, more preferably 0.02 to 1.4%, still morepreferably 0.03 to 1.3%.

When the content is less than 0.01% sufficient effects for inhibitingthe water repellency may not be attained. A further addition exceeding1.5% makes the effects saturated and may, in some cases, may result inno significant differences.

As long as the granular jelly beverage for medication exerts the maskingeffect, the effect to assist the swallowing, and the effect to improvethe taste, all of which effects are intended by the present invention,it can contain, besides the above-mentioned essential ingredients,gelling promoting agents, saccharides which are nutrient sources,sweeteners and other additives including flavoring agents.

For instance, as the gelling promoting agent, calcium lactate can beadded to 0.1 to 2.0%.

The granular jelly beverage for medication according to the presentinvention, which beverage is composed of the above-mentioned ingredientsdoes not suppress an intrinsic natural sweet or sour taste of a crudedrug, herbal medicine or the like. It rather has effects to make thesetastes stand out and to improve the overall taste. This facilitates thetaking of crude drug, herbal medicine or the like which has a uniquebitter taste, astringent taste, sour taste or sweet taste. Thus, it canpreferably be used particularly when children or the like take a crudedrug, herbal medicine or the like.

Next, properties of the granular jelly beverage for medication accordingto the present invention will be described.

This jelly beverage has circumferentially water or the like and is anaggregate of granular jellies whose shape is uniform or not uniform. ThepH thereof is preferably 2.5 to 5.0, more preferably 2.7 to 4.5,particularly preferably 3.0 to 4.0.

In cases where the pH is less than 2.5, a sour taste stands out andbitter and astringent tastes of a crude drug or herbal medicine arestrongly perceived. In cases where the pH is more than 5.0, the sour andastringent tastes of a crude drug or herbal medicine are stronglyperceived and the palatability deteriorates, which are not preferred.

Also, the jelly strength at 20° C. is preferably 10 to 100 g/cm², morepreferably 20 to 80 g/cm², still more preferably 20 to 70 g/cm².

In cases where the jelly strength is less than 10 g/cm², it cannot besaid that there are no possibilities to cause troubles such asaspiration for those who have difficulty in swallowing. In cases wherethe jelly strength is more than 100 g/cm², the granular jelly may be toohard to be smoothly swallowed.

Also, the maximum length of the granular jelly, that is, when a linesegment across granular jelly's inside is assumed in the granular jellyusually having a shape of pillar, cone or oval sphere, the length of thelongest line segment is preferably 1 to 10 mm, more preferably 1 to 8mm.

In cases where the maximum length of the granular jelly is less than 1mm, the granular jelly is rendered very close to a form of paste and mayadhere to and remain in the throat. In cases where the maximum length ismore than 10 mm, the granular jelly may clog the throat and its adhesionwith the drug such as the herbal medicine may possibly deteriorate.

Since the granular jelly beverage for medication according to thepresent invention has the above-mentioned shape and jelly strength, itcoats herbal medicine or the like in the form of granule or powder withlow specific gravity in the granular jelly beverage and the granularjelly beverage does not separate from the drug in the mouth. Because ofthis, by using the granular jelly for medication according to thepresent invention, even a crude drug and/or herbal medicine in the formof granule or powder which readily adhere to the throat does not remainin the mouth or the throat. And, healthy subjects and patients in frailhealth or suffering from various diseases, who find difficulties inswallowing the drug, can readily take a relatively large dose of theherbal medicine.

Further, since the granular jelly beverage for medication according tothe present invention can firmly coat the drug, it is suitable fortaking a large dose of crude drug, herbal medicine, or the like. Forexample, 2 to 3 g of granules of the drug is firmly coated in 20 ml ofthe granular jelly beverage for medication according to the presentinvention, which allows this drug to be easily taken.

For example, in the case of a granular herbal medicine, a dose per oneapplication is usually about 2 to 3 g.

With a granular jelly having its maximum length of 1 to 10 mm, granuleswhich are widely used as a formulation of herbal medicine can be readilycoated.

Furthermore, although the granular jelly beverage for medicationaccording to the present invention has the coating function as describedabove, it is mainly composed of water. Also, when it is warmed to nearbody temperature (about 37° C.), the jelly strength decreases and thecoating function is lost. Thus, there are no effect on thedisintegration and dissolution property of the drug. Since there arealso no interaction between the granular jelly beverage and the drug,pharmacological effects of crude drugs or herbal medicines are notimpaired.

Since the granular jelly beverage for medication is a non-sugarbeverage, it is suitable for diabetic patients. Also, since the beverageis unlikely to cause a cavity even when taken immediately before goingto bed, it is suitable for children. Further, since the beverage goesthrough a sterilization step, it can be safely used by patients withweak physical strength, decreased resistance, or compromised immunity,as well as children.

Examples of a drug which facilitates the swallowing when taken withgranular jelly beverage for medication according to the presentinvention include drugs using herbal medicine prescriptions or crudedrugs (Korean ginseng, various herbs or the like) which have beenapproved by the Ministry of Health, Labour and Welfare.

Examples of the type of formulation include solid formulations such aspowders, granules, balls, capsules, powdered extracts or tablets andliquid formulations such as extracts or syrups.

Next, an example of a method for producing the granular jelly beveragefor medication according to the present invention will now be describedreferring to the drawings. It should be noted that the method forproducing the granular jelly beverage for medication is not limited tothe method described below.

FIG. 1 is a flow diagram showing an example of an embodiment of themethod for producing the granular jelly beverage for medicationaccording to the present invention.

As shown in FIG. 1, the bitterness masking auxiliary ingredient (b) andthe aggregation-inhibiting gelling ingredient (c) or the gellingingredient (c-1) are first subjected to powder mixing and then theresulting powder mixture is fed into warmed water (at not less thanabout 50° C.) and stirred for a prescribed time to obtain asubstantially uniform mixture. Next, the bitterness masking ingredient(a) is fed and as necessary the ingredient for inhibiting waterrepellency (f) is fed. After the resulting mixture is mixed for aprescribed time, the aggregation-inhibiting gelling ingredient (c) isfurther fed and stirred to obtain a substantially uniform mixture.Thereafter, to the obtained mixture, the taste adjusting ingredient (d)is fed and as necessary, the flavoring agent or the like is added. Andthen, the whole mixture is adjusted (filled up) with water (e). Theresultant is filled in a container and is as necessary, subjected tosterilization, cooling and the like, thereby obtaining the granularjelly beverage for medication.

In cases where the aggregation-inhibiting gelling ingredient (c) and/orthe gelling ingredient (c-1) is/are added separately in twice dividedlyinto 2 portions, the aggregation-inhibiting gelling ingredient (c) maybe first added and then the gelling ingredient (c-1) may be added. Theseingredients may be added in the reverse order. Or, theaggregation-inhibiting gelling ingredient (c) may be added twice.

When the solution is stirred and mixed, it is preferred that thesolution be warmed to 50 to 100° C., more preferably to 70 to 100° C.while being stirred and mixed.

FIG. 2 is a flow diagram showing another example of an embodiment of themethod for producing the granular jelly beverage for medicationaccording to the present invention. In the method for production in thisexample, the bitterness masking auxiliary ingredient (b) is first fedinto water warmed to not less than about 50° C. and stirred for aprescribed time to substantially uniformly mix the resultant. Next, thebitterness masking ingredient (a) is fed and as necessary, theingredient for inhibiting water repellency (f) is fed. The resultingmixture is stirred for a prescribed time, thereby obtaining a mixture(first mixture). Further, the aggregation-inhibiting gelling ingredient(c) mixed in advance with water warmed to not lower than 50° C. is fedinto the first mixture and stirred, thereby obtaining a substantiallyuniform mixture (second mixture). Thereafter, to the obtained secondmixture, the taste adjusting ingredient (d) is fed and as necessary, theflavoring agent or the like is added. And then, the whole mixture isadjusted (filled up) with water (e). The resulting mixture is filled ina container and as necessary subjected to sterilization, cooling or thelike, thereby obtaining the granular jelly beverage for medication.

As shown in FIG. 2, the aggregation-inhibiting gelling ingredient (c)and the gelling ingredient (c-1) may be added in a preparation tank atonce, not separately.

The order of mixing the bitterness masking ingredient (a), thebitterness masking auxiliary ingredient (b), aggregation-inhibitinggelling ingredient (c) and at least a part of water (e) is notrestricted. To the mixture obtained by mixing these (a, b, c and e), thetaste adjusting ingredient (d) may be added and mixed.

In the method for producing the granular jelly beverage for medication,the bitterness masking ingredient (a), the bitterness masking auxiliaryingredient (b), aggregation-inhibiting gelling ingredient (c) and atleast a part of water (e) are substantially uniformly mixed to obtain amixture and thereafter, the taste adjusting ingredient (d) is added tothe mixture. By doing so, aggregation or the like is unlikely to occurin the granular jelly beverage and thus the granular jelly beveragehaving a preferred mode for coating crude drug, herbal medicine or thelike can be produced.

The granular jelly beverage for medication can preferably be used when adrug such as crude drug, herbal medicine or the like having a bittertaste as well as sour taste is taken. As a way of taking such a drug,for example, the drug such as crude drug, herbal medicine or the like isfirst put in the mouth and then the granular jelly beverage formedication, instead of water, is put in the mouth. Thereafter, the drugand granular jelly beverage for medication may be allowed to flow downto the throat to be swallowed. Also, the drug may be put in the granularjelly beverage for medication, which is placed in advance in a containersuch as a cup, and mixed. Thereafter, this mixture may be swallowed.

EXAMPLES

The present invention will be described in more detail by way ofExamples and Comparative Example below, but the present invention is byno means limited to these Examples.

Example 1

According to the method for production shown in FIG. 1, sorbitol anddextran were added to water (50 parts) warmed to about 50° C. Soybeanlecithin was further added thereto while keeping the water temperatureat 50° C. and the mixture was then stirred. Subsequently, xanthane gumdissolved in water (20 parts) warmed in advance was gradually added,thereby obtaining a mixture. To this mixture, citric acid was added andstirred. A flavoring agent and water were further added thereto and thefinal total volume was adjusted. The resultant was filled in a containerand allowed to cool, thereby obtaining a granular jelly beverage formedication. The blending percentage of each ingredient is shown in Table1.

The pH of the granular jelly beverage for medication was 4.2. The jellystrength thereof was 40.0 g/cm². The maximum length of granular jellywas 5.0 mm. The water reduction rate was 0.5%.

The jelly strength was measured by the method described later.

TABLE 1 Example 1 Mass % Sorbitol (b: bitterness masking auxiliaryingredient) 15.0 Dextran (c-1: gelling ingredient) 1.0 Xanthane gum (c:aggregation-inhibiting gelling ingredient) 0.2 Citric acid (d: tasteadjusting ingredient) 0.5 Soybean lecithin (a: bitterness maskingingredient) 0.2 Flavoring agent 0.1 Purified water (e: water) 83.0 Totalamount 100.0

Example 2

According to the method for production shown in FIG. 2, erythritol andsorbitol were added to water (50 parts) warmed to about 50° C. Cacao fatand oil were further added thereto while keeping the water temperatureat 50° C. and the mixture was then stirred, thereby obtaining a mixture(first mixture). Subsequently, agar, locust bean gum and sucrose fattyacid ester were added in water (20 parts) warmed in advance at about 50°C. and stirred to obtain a mixture. And then, this resulting mixture wasgradually added to the first mixture and stirred, thereby obtaining thesecond mixture. Thereafter, to the second mixture, citric acid was addedand stirred. A flavoring agent and water were further added thereto andthe final total volume was adjusted. The resultant was filled in acontainer and allowed to cool, thereby obtaining a granular jellybeverage for medication. The blending percentage of each ingredient isshown in Table 2.

The pH of the granular jelly beverage for medication was 3.3. The jellystrength thereof was 45.5 g/cm². The maximum length of granular jellywas 5.0 mm. The water reduction rate was 2.0%.

TABLE 2 Example 2 Mass % Erythritol (b: bitterness masking auxiliaryingredient) 5.0 Sorbitol (b: bitterness masking auxiliary ingredient)5.0 Agar (c-1: gelling ingredient) 0.1 Locust bean gum (c:aggregation-inhibiting gelling ingredient) 0.2 Citric acid (d: tasteadjusting ingredient) 1.5 Cacao fat and oil (a: bitterness maskingingredient) 0.4 Sucrose fatty acid ester (f: ingredient for inhibiting0.1 water repellency) Flavoring agent 0.2 Purified water (e: water) 87.5Total amount 100.0

Comparative Example

Erythritol, hydrogenated maltose starch syrup, locust bean gum, xanthanegum, carrageenan and calcium lactate were added to water (50 parts)warmed to about 50° C. A homogenized sucrose fatty acid ester and cacaofat and oil were added thereto while keeping the water temperature at50° C. and the mixture was then stirred. A flavoring agent, sweetenerand water were further added thereto and the final total volume wasadjusted. The resultant was filled in a container and allowed to cool,thereby obtaining a bitterness masking granular jelly without a tasteadjusting ingredient. The blending percentage of each ingredient isshown in Table 3.

The pH of the bitterness masking granular jelly beverage was 6.6. Thejelly strength thereof was 39.8 g/cm². The maximum length of granularjelly was 5.0 mm. The water reduction rate was 1.8%.

TABLE 3 Comparative example Mass % Erythritol 10.0 Hydrogenated maltosestarch syrup 4.0 Locust bean gum 0.1 Xanthane gum 0.05 Carrageenan 0.2Calcium lactate 0.1 Cacao fat and oil 0.8 Flavoring agent 0.2 Stevia0.05 Sucrose fatty acid ester 0.02 Purified water 84.48 Total amount100.0

Reference Example

According to the method for production shown in FIG. 1, erythritol,xylitol and agar were added to water (50 parts) warmed to about 50° C.Soybean lecithin was further added thereto while keeping the watertemperature at 50° C. and the mixture was then stirred. Subsequently,sucrose fatty acid ester was gradually added to water (20 parts) warmedin advance and stirred, thereby obtaining a mixture. When citric acidwas added to this mixture, lumps were formed. Although the mixture wasstirred, the lumps were not able to be dissolved. Thus, due to lack ofan aggregation-inhibiting gelling ingredient, aggregation occurred andan appropriate gel was not able to be formed in this example. Theblending percentage of each ingredient in this example is shown in Table4.

TABLE 4 Reference example Mass % Erythritol 5.0 Xylitol 5.0 Agar 0.2Citric acid 1.5 Soybean lecithin 0.2 Sucrose fatty acid ester 0.01Purified water 88.09 Total amount 100.0[Determination of Jelly Strength]Measuring apparatus: rheometer (manufactured by Rheotech, Type:RT-2020J)Plunger: 1 cmφCompression rate: 2 cm/minMeasurement Method:

After left to stand at 20° C. for not less than 15 hours, a sample wastaken out such that a jelly was not broken. The sample was carefullytaken out with an appropriate container (3 cmφ×2 cm) so as not to bebroken. The strength of the sample was measured using theabove-mentioned measuring apparatus and the jelly strength wascalculated according to the following formula (1):Jelly strength (g/cm²)=Measured strength(g)/0.785 (cm²)  (1)

Here, 0.785 cm² is the surface area of the plunger.

[Performance Evaluation]

The granular jelly beverage of each example was subjected to thefollowing sensory evaluation by human subjects. The obtained results areshown in Tables 4 to 10.

(Conditions for Sensory Evaluation)

As shown below, a prescribed amount of a drug to be evaluated, whichdrug was prescribed in the basis of herbal remedy, was treated with aprescribed amount of the granular jelly beverage of each example. Theobtained sample (granular jelly beverage containing herbal medicine) wastaken by six test subjects (healthy adults; five males and one female)and evaluated for each of the tastes at a prescribed time as describedbelow.

In regard to a sweet taste, the cases where it was not different fromthat of a herbal medicine alone was indicated as “III”, the cases whereit was slightly stronger than that of the herbal medicine itself wasindicated as “II”, and the cases where it was stronger than that of theherbal medicine itself was indicated as “I”.

In regard to a bitter taste, the cases where it was not different fromthat of a herbal medicine itself was indicated as “III”, the cases whereit was slightly weaker than that of the herbal medicine itself wasindicated as “II”, and the cases it where the bitter taste was notperceived was indicated as “I”.

In regard to a sour taste, the cases where it was weaker than that of aherbal medicine itself was indicated as “IV”, the cases where it was notdifferent from that of the herbal medicine itself was indicated as“III”, the cases where it was slightly stronger than that of the herbalmedicine itself was indicated as “II”, and in the cases where it wasstronger than that of the herbal medicine itself was indicated as “I”.

In regard to a pungent taste, the cases where it was not different fromthat of a herbal medicine itself was indicated as “III”, the cases whereit was slightly weaker than that of the herbal medicine itself wasindicated as “II”, and the cases it where the pungent taste was notperceived was indicated as “I”.

In regard to an unpleasant smell, the cases where an unpleasant smell ofa herbal medicine existed was indicated as “III”, the cases where theunpleasant smell of the herbal medicine slightly existed was indicatedas “II”, and the cases it where no unpleasant smells of the herbalmedicine existed was indicated as “I”.

In regard to a smell of flavoring agent, the cases where the smell offlavoring agent existed was indicated as “III”, the cases where thesmell of flavoring agent slightly existed was indicated as “II”, and thecases where no smells of flavoring agent existed was indicated as “I”.

(1) Drugs to be Evaluated

(i) Orengedokuto Extract Granules (manufactured by Tsumura & Co., No.15)

(ii) Shofusan Extract Granules (manufactured by Tsumura & Co., No. 22)

(iii) Goshuyuto Extract Granules (manufactured by Tsumura & Co., No. 31)

(iv) Unseiin Extract Granules (manufactured by Tsumura & Co., No. 57)

(v) Jizusoippo Extract Granules (manufactured by Tsumura & Co., No. 59)

(vi) Saikoseikanto Extract Granules (manufactured by Tsumura & Co., No.80)

(vii) Saireito Extract Granules (manufactured by Tsumura & Co. No. 114)

(2) Amount of Drugs

The amount of each drug was 1.25 g.

(3) Preparation of Samples

To the granular jelly beverage (10 g), the drug (1.25 g) was added andstirred well.

The test subject put the jelly mixed with the drug and stirred well inher/his mouth and, 10 seconds later, took it out. And, 5 seconds later,they conducted evaluation.

TABLE 5 Orengedokuto Comparative Extract Granules Example Example 1Example 2 Sweet taste Absent II II II Bitter taste Present II II I Sourtaste Absent III II II Pungent taste Absent III III III Herbal odor — III I (Smells of herbs) Jelly flavor — II II III (Flavoring strength)

TABLE 6 Shofusan Comparative Extract Granules Example Example 1 Example2 Sweet taste Slightly present II II II Bitter taste Present II II ISour taste Absent III III II Pungent taste Absent III III III Herbalodor — II I I (Smells of herbs) Jelly flavor — II II III (Flavoringstrength)

TABLE 7 Goshuyuto Comparative Extract Granules Example Example 1 Example2 Sweet taste Absent II II II Bitter taste Slightly Present III I I Sourtaste Absent III II II Pungent taste Present II I I Herbal odor — II I I(Smells of herbs) Jelly flavor — II II III (Flavoring strength)

TABLE 8 Unseiin Extract Comparative Granules Example Example 1 Example 2Sweet taste Absent II I I Bitter taste Present II II II Sour tasteAbsent III II II Pungent taste Absent III III III Herbal odor — II I II(Smells of herbs) Jelly flavor — II III II (Flavoring strength)

TABLE 9 Jizusoippo Comparative Extract Granules Example Example 1Example 2 Sweet taste Slightly present II II II Bitter taste Slightlypresent I I I Sour taste Absent III II II Pungent taste Absent III IIIIII Herbal odor — II I I (Smells of herbs) Jelly flavor — II II III(Flavoring strength)

TABLE 10 Saikoseikanto Comparative Extract Granules Example Example 1Example 2 Sweet taste Absent II II II Bitter taste Present II II II Sourtaste Absent III II II Pungent taste Absent III III III Herbal odor — III II (Smells of herbs) Jelly flavor — II II II (Flavoring strength)

TABLE 11 Saireito Extract Comparative Granules Example Example 1 Example2 Sweet taste Absent II II II Bitter taste Slightly Present II II I Sourtaste Slightly Present IV III III Pungent taste Slightly Present I I IHerbal odor — I I I (Smells of herbs) Jelly flavor — II II III(Flavoring strength)[Discussion on Performance Evaluation]

As shown in Tables 5 to 11, when the granular jelly beverages formedication of Examples 1 and 2 were taken in conjunction with the herbalmedicine (i) to (vii), there was a tendency that the sweet taste andsour taste became stronger. Because of this tendency, even if the bittertaste existed, it was different from a bitter taste which makes theherbal medicine difficult to be swallowed. Rather, there was a tendencythat the bitter taste and pungent taste were weakened and the herbalmedicine was more easily taken. In addition, it was able to be confirmedthat, by using the granular jelly beverages for medication of theseExamples, the drug was more easily swallowed with no unpleasant smellsof herbs existing and tastes being improved.

On the other hand, in the Comparative Example (conventional bitternessmasking granular jelly beverage), the sour taste and pungent taste werenot different from those of the herbal medicine itself and the smell ofherbs remained. Thus, it was not suitable for taking the herbalmedicine.

INDUSTRIAL APPLICABILITY

According to the present invention, by using the aggregation-inhibitinggelling ingredient in addition to the bitterness masking ingredient, thebitterness masking auxiliary ingredient and the taste adjustingingredient, the granular jelly beverage for medication and the methodfor production thereof can be provided, which granular jelly beverage isable to, without impairing the pharmacological effects of a crude drugand/or herbal medicine, mask the bitterness of these drugs and coat thedrugs for easier swallowing as well as to have an good taste even aftermixed with the drug composed of crude drug and/or herbal medicine.

What is claimed is:
 1. A granular jelly beverage for medication used fortaking a crude drug(s) and/or herbal medicine(s), said granular jellybeverage for medication comprising: (a) 0.1 to 15.0% by mass of abitterness masking ingredient comprising a plant fat and oil and/oranimal fat and oil; (b) 5.0 to 20.0% by mass of a bitterness maskingauxiliary ingredient comprising a sugar alcohol; (c) 0.1 to 5.0% by massof at least one type of an aggregation-inhibiting gelling ingredientselected from the group consisting of carrageenan, gellan gum, locustbean gum, xanthan gum, guar gum, pectin, tapioca starch, and starch; (d)0.1 to 5.0% by mass of at least one type of a taste adjusting ingredientselected from the group consisting of acids, derivatives thereof andsalts thereof; and (e) a balance of water, wherein: the granular jellybeverage comprises components (a) to (d) in the form of a plurality ofjelly granules; the granular jelly beverage has a pH of 2.5 to 5.0; thejelly granules have a maximum length of 1 to 10 mm; and the granularjelly beverage is packaged without the crude drug(s) and/or herbalmedicine(s) such that the granular jelly beverage is adapted to be mixedby an end user with the crude drug(s) and/or herbal medicine(s).
 2. Thegranular jelly beverage for medication according to claim 1, furthercomprising at least one type of a gelling ingredient (c−1) selected fromthe group consisting of agar, furcellaran, gelatin, curdlan, psylliumseed gum, alginic acid, alginate, mannan, tamarind gum, dextran,carboxymethyl cellulose, carboxymethyl cellulose sodium, andmethylcellulose.
 3. The granular jelly beverage for medication accordingto claim 2, wherein, in a total amount of said aggregation-inhibitinggelling ingredient (c) and said gelling ingredient (c−1), saidaggregation-inhibiting gelling ingredient (c) is 5.0 to 95.0% by mass ofsuch total.
 4. The granular jelly beverage for medication according toclaim 1, which has a pH of 2.7 to 4.5.
 5. The granular jelly beveragefor medication according to claim 1, further comprising 0.01 to 1.5% bymass of at least one type of an ingredient for inhibiting waterrepellency (f) selected from the group consisting of sucrose fatty acidesters, glycerine fatty acid esters, sorbitan fatty acid esters,propylene glycols and propylene glycol fatty acid esters.
 6. Thegranular jelly beverage for medication according to claim 1, wherein thejelly granules have a jelly strength at 20° C. of 10 to 100 g/cm². 7.The granular jelly beverage for medication according to claim 1, whereinsaid plant fat and oil of said bitterness masking ingredient (a) is atleast one selected from the group consisting of cacao fat and/or oil,lecithin, soybean oil, salad oil, edible safflower oil, sunflower oil,canola oil, corn oil, rice bran oil, peanut oil, olive oil, sesame oil,linseed oil, coconut oil, palm oil, mixed oil, margarine and shortening;and said animal fat and oil is at least one type selected from the groupconsisting of lard, unsalted butter, butter, cheese, cream, meat fats,and fish oils.
 8. The granular jelly beverage for medication accordingto claim 1, wherein said sugar alcohol in said bitterness maskingauxiliary ingredient (b) is at least one selected from the groupconsisting of hydrogenated maltose starch syrup, hydrogenated starchsyrup, hydrogenated lactose, xylitol, erythritol, sorbitol and mannitol.9. The granular jelly beverage for medication according to claim 1,wherein said taste adjusting ingredient (d) is at least one selectedfrom the group consisting of adipic acid, L-ascorbic acid, L-asparaticacid, L-arginine, L-glutamic acid, citric acid, glucono delta lactone,gluconic acid, succinic acid, DL-tartaric acid, L-tartaric acid, lacticacid, fumaric acid, butyric acid, DL-malic acid, derivatives thereof andsalts thereof.
 10. The granular jelly beverage for medication accordingto claim 1, wherein said crude drug(s) and/or herbal medicine(s) are/isat least one of formulation selected from the group consisting ofpowders, granules, balls, capsules, powdered extract agents, tablets,extracts and syrups.
 11. A method for producing said granular jellybeverage for medication according to claim 1, said method comprisingmixing said bitterness masking ingredient (a), said bitterness maskingauxiliary ingredient (b), said aggregation-inhibiting gelling ingredient(c) and at least a part of said water (e) to obtain a mixture; andthereafter mixing said taste adjusting ingredient (d) into said mixture.